Monthly Archives: November 2013

In a recent judgment the Supreme Court of India, revoked the powers of the drug regulators in the country sighting several irregularities which were considered serious in nature. The judgment which came in January has put the Pharma industry in jeopardy as many as 162 clinical trials are awaiting approval from the health ministry which has been barred from giving any approvals by the SC.

Death toll resulting from clinical trials was put at 2644 for the past five years. Around 11792 adverse effects were also recorded in this period. This number excludes the deaths. 506 cases of adverse effects were directly related to the clinical trial. The research firm Frost and Sullivian puts the cost of the Indian pharma industry to be 500 million dollars which is expected to grow by 2016 to one billion dollars. A move to stop clinical trials in India would mean firms would start looking for other favorable destination for clinical trials like Singapore and Malaysia.

The Health Ministry on the other hand is banking on the recommendations made by Ranjit Roy Choudhary committee and the amendments to Drugs and Cosmetics (Amendment Bill) of 2013 to prevent a shutdown like scenario of the clinical trial industry. The judgements have caused a flutter in the pharmaceutical industry and are leaving an unsure future for clinical trials in India. The judgments were announced after the SC heard a public interest litigation filed by an Indore based NGO, in January this year.

The above situation explores the complex relationship between the clinical trials and law. India is a hot destination for clinical trials not only for home grown pharma but also for other countries like the US which has since withdrawn in the wake of tougher regulations and stricter implementations. India is the leading producer for many cheap drugs and vaccines which are in huge demand worldwide. If the chain is pulled on clinical trials, it would affect the industry to a great extent. Whether this would hamper innovation and invention in the field of drugs and medicine is yet to be seen. Industry awaits the decision keeping its fingers crossed.

The Supreme Court has declared that any trial from now onwards would have to undergo three layers of inquiry before getting the final approval. The court has blocked the earlier approved 157 clinical trials saying that such trials should help the people of the country and not others. The three tier scrutiny system comprised of New Drug Advisory Committee, technical committee and apex committee. The stringent norms also demand that the trials on patient be video recorded and preserved.

The three tier system is a tougher method of regulation as only five trials were approved under it, between January 1 to August 31. The five trials are allowed on the condition of audio and video recording of the trial, taking informed consent of the subjects. The required documents have to be presented to the court while maintaining the confidentiality and privacy of the subjects who have participated in the trials. The apex court has come down heavily on the practice of paying the investigators by the pharmaceutical companies, as this may seriously come in the way of honest discharge of their duties. The Court took notice of the fact that if such practices continued then adverse events would not be reported, and cover up would go on the sly. The court maintained that a panel of independent investigators should be set up by the government. These investigators should be paid by the government itself, ruling out any corporate interference.

Thus the current scenario depicts strict regulations which are expected to take care of the participating subjects and also control the kinds of trials approved. Whether these measures and norms succeed in preventing deaths on trial is yet to be seen.